A first patient was treated in Pittsburgh, Pennsylvania in the United States in early April 2024 as part of the new clinical trial sponsored by Hemerion.
This study (HTX-GBM-01) is designed to confirm the safety and feasibility of the Pentalafen® / Heliance® combination therapy in the treatment of glioblastoma, the most common and aggressive form of brain cancer. This is the first time this therapy has been used in an operating room in the United States.
Pentalafen® / Heliance®: a therapeutic solution that complements existing treatments to improve patient survival and quality of life
Hemerion is developing a therapeutic solution that combines a photosensitizing drug (Pentalafen®) and an illumination platform (Heliance®).
This combination therapy is used in the operating room immediately after tumor resection, to destroy as many tumor cells as possible deep in the tissue, without damaging healthy cells. It could significantly reduce the risk of recurrence and improve patient survival and quality of life.
A significant clinical advancement
The clinical trial, sponsored by Hemerion, is designed to confirm the safety and feasibility of intraoperative photodynamic therapy (PDT), using the drug Pentalafen® and the Heliance® device. Additionally, the trial will assess the efficacy of increasing light doses to optimize the parameters of the therapy.
This is a crucial step in preparing for the pivotal study that will confirm the therapeutic efficacy of the treatment and pave the way for its use as a new standard of care.
A first in the USA
The clinical trial is being conducted at the University of Pittsburgh Medical Center (UPMC) Presbyterian Hospital and UPMC Hillman Cancer Center.
The first patient underwent tumor resection surgery on April 11, 2024. This marks the first instance of the Pentalafen®/Heliance® combination therapy being used in the United States.
The operation was meticulously prepared by the Hemerion team, which introduced the latest versions of the Pentalafen®/Heliance® combination to the United States.
Hemerion also provided comprehensive training to the neuro-oncology and neurosurgery teams involved in the clinical trial.
They were led by Jan Drappatz, M.D., director of the Neuro-oncology Program at UPMC and Associate Professor at the University of Pittsburgh School of Medicine and Costas Hadjipanayis, M.D., Ph.D., executive vice chair of UPMC Neurological Surgery, director of the UPMC Center for Image-Guided Neurosurgery and co-director of the department’s Brain Tumor Program .
The procedure involved:
- The administration of Pentalafen® to the patient was conducted six hours prior to surgery.
- Following tumor removal, the illumination sequence was set up, including dosimetry, the illumination sequence, and the placement of the diffuser in the surgical cavity.
The next patients will be included in the coming weeks, at the conclusion of the observation period scheduled after the first treatment.
“Our team was eager to expand the clinical trials in the US since the initial studies in France since 2017 have yielded promising results. If approved, we think this therapy could represent a genuine source of hope for our patients and their families.”
Dr. Jan Drappatz, Neuro-Oncologist
Principal Investigator, UPMC
“Given its potential to address the primary challenge currently faced by surgical teams, namely the eradication of infiltrating cancer cells in the vicinity of the operating cavity, we are hopeful this new technology may be a significant advancement in glioblastoma surgery.”
Dr. Costas Hadjipanayis, Neurosurgeon
Co-investigator, UPMC